Registration Dossier

Administrative data

Description of key information

Oral LD50 > 2000 mg/kg bw
Test on dermal and inhalation toxicity are not required for the registration tonnage band.

Key value for chemical safety assessment

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The test substance has very low vapor pressure and high melting point, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.

Exposure considerations for workers:
Production is performed in closed processes without isolation of reaction products. Isolated products consist only of liquid formulations. In addition, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Risk management measures established for workers and professionals are considered sufficient to enable safe handling and use of the final products containing the formulated dye.

Exposure considerations for professionals and consumers:
The substance and its related products are sold for industrial application only. The substance is not marketed for professional and consumer applications.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The physicochemical and toxicological properties suggest a low potential for significant rate of absorption through the skin. Furthermore the results of laboratory animal studies performed to assess skin irritation and skin sensitization potential displayed no acute dermal toxicity. In addition, following acute oral application the test substance does exacerbate systemic toxicity effects. Taken together, due to the good water solubility oral ingestion and subsequent gastro-intestinal absorption is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity, dermal exposure is considered to be negligible for systemic toxicity. Therefore the study will be waived and the intrinsic property/toxicity potential can be extrapolated from the acute oral route administration.

Additional information

Special test to assess the acute toxicity potential of the CAS 28950-61-0 was conducted only for the oral route. Two groups, each of three female rats, were treated with test item by oral gavage administration at a dosage of 2000 mg/kg body weight. All animals survived until the end of the study period. Soft feces were recorded in one animal at the 3-hour observation. Otherwise, no clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. Thus, the median lethal dose of test item after single oral administration to female rats, observed over a period of 14 days is was greater than 2000 mg/kg body weight.

The substance under registration (CAS 28950-61-0) belongs to the category of Stilbene Fluorescent Whitening Agents.

All members of this category are organic salts with high molecular weight, solids with high thermal stability, low Kow and high to very high water solubility. They do not show acute toxic effects after oral, inhalation, and dermal administration and they are mainly excreted in the faeces in a few hours by oral administration and practically not absorbed by skin, therefore no systemic effects are expected.


Justification for selection of acute toxicity – inhalation endpoint
data waiving

Justification for selection of acute toxicity – dermal endpoint
data waiving

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).

The available experimental data are adequate for classification and labelling and the results show that the substance is not classified for acute toxicity, according to the CLP Regulation (EC 1272/2008).